Essential Health and Safety Requirements for machinery.
Essential Health and Safety Requirements – referred to as EHSRs – define all the aspects or potential risks applicable to machinery, which the manufacturer must assess and, if necessary, resolve. Listed in Annex I of the Machinery Directive 2006/42/EC and Annex III of the Machinery Regulation (EU) 2023/1230, these requirements briefly and rather generically provide the fundamental principles for the manufacture of safe machinery, while technical design details are mostly covered by harmonised standards. The EHSRs are divided into six distinct sections:
1. general requirements applicable to all machinery
2. supplementary requirements for specific types of machinery, namely:
2.1 machinery for foodstuffs, cosmetics or pharmaceutical products;
2.2 portable hand-held or hand-guided machinery;
2.3 machinery for working wood and material with similar physical characteristics;
2.4 machinery or related products for plant protection products application;
3. requirements for mobility of machinery or related products;
4. requirements to offset risks due to lifting operations;
5. requirements for machinery intended for underground work;
6. risks associated with the lifting of persons – in addition to point 4.
The part relating to machinery or related products for the plant protection products application has been added by the Machinery Regulation (EU) 2023/1230; the Directive 2006/42/EC did not cover it.
The EHSRs are specific chapters of the annex that address a specific risk or machinery-related aspect. In fact, in common usage they are identified by the number of the relevant chapter. For example: quoting EHSR 1.1.2 refers to the essential safety requirement on the Principles of Safety Integration, which can be found in chapter 1.1.2 of Annex I of the Directive 2006/42/EC, or Annex III of the Machinery Regulation (EU) 2023/1230. The Machinery Regulation (EU) 2023/1230 does not significantly alter the essential safety requirements, and the numbering given by the Machinery Directive 2006/42/EC has been preserved. However, it introduces a new requirement, a new aspect that the manufacturer must assess and ensure: the EHSR 1.1.9 on Protection against Corruption. In addition, it updates and modifies some content and chapter titles.
Before placing the machinery on the market or putting it into service, the manufacturer must ensure that it meets all the applicable essential health and safety requirements. The list of applicable requirements must be included in the technical file, together with the references to the standards and technical specifications observed during the design phase. The manufacturer must clearly indicate when a specific requirement is not applicable; simply omitting it from the list is not sufficient. To comply with these legal requirements, a commonly used approach in the industry is to include all this information in the risk analysis, considering that it must also be archived in the technical file. It is during the risk analysis that the manufacturer should reasonably verify the essential safety requirements and then define any appropriate design solutions to meet them. Including all this information in the risk analysis summary document the during the verification process can thus reconcile the analysis while also contributing to satisfying the legal requirements. However, the manufacturer is free to procced as they see fit, as long as the technical file includes the list of applicable essential safety requirements and the technical standards observed during design phase